The absence of an FDA commissioner affords Chief Counsel Daniel Troy a greater role in keeping the agency within its legal and regulatory bounds in conducting enforcement activity, panelists noted at a Washington Legal Foundation briefing Oct. 3.

Larry Pilot, a partner in the Washington, D.C. law firm of McKenna & Cuneo and the first director of compliance for FDA's device programs (1974-77), characterized Troy's appointment last August as the "silver lining" accompanying the lack of a permanent head.

"This chief counsel, who is there right now, should examine how personnel within the agency are discharging their responsibility with regard to the explicit requirements of law and regulation," Pilot asserted. "We have an opportunity with the new chief counsel to put some emphasis on what is the law, the regulations, because those subject to regulations have the responsibility to comply, but they do have some rights."

As a partner at law firm Wiley, Rein & Fielding, Troy represented WLF in challenging FDA's regs governing off-label information in journal articles and textbooks. Although FDA won the suit on appeal, the agency shifted its policies closer to the WLF position.

Pilot singled out FDA's device inspectional activity for legal and administrative reforms. Referring to warning letters as "a creature of the [former FDA Commissioner David] Kessler," Pilot claimed that "other than to embarrass recipients, the warning letter has no practical value - except for the foreign manufacturer."

In those letters, "the 'detention' language places upon the foreign manufacturer or importer of the product the burden to go forward and demonstrate to a court that the agency has been arbitrary, capricious or abuses discretionary authority," Pilot said. "That is unfair."

FDA should reinstate regulatory letters in lieu of warning letters, Pilot recommended. Regulatory letters, abolished in May 1991, required companies to respond satisfactorily within 10 days, or face enforcement action. Pilot also took issue with FDA's Form 483 inspection report. "The expectation is whatever goes on to a 483 is going to represent the objectionable conditions that are going to be tied into violation of law or regulation," he said. However, "oftentimes the [recorded] observations have no bearing whatsoever on what is complying with law or regulation."

Warning Letter, Form 483 Should Be Revisited By FDA Counsel, Pilot Suggests

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